MAUDE Adverse Event Report: COVIDIEN LP BARRX BEACON EUS ACCESS SYSTEM; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Model Number	DSA-090-01
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the physician tried to gain access to the patient's common bile duct during the rendezvous procedure but they could not pass the guide wire through the stricture and it kept going toward the hilum.The patient had a distal biliary obstruction with a common duct diameter of around 12 mm.They tried to put the stylet back into the cannula to make the hook straight again before removing it but was unable to insert cannula to the end.The cannula would not go back into the device and they could not remove without the tip being hooked.The incident occurred on first pass.Ercp (endoscopic retrograde cholangiopancreatography) was attempted just prior to the rendezvous attempt, but ercp cannulation had failed.The physician also attempted to use a 90 degree access device, the guide wire inserted but it again kept going into the hilum.The guide wire was removed and the stylet was re-inserted prior to the removal of the 90 degree catheter.At no point did the guide wire successfully make the turn and proceed antegrade.There was no immediate complications noted.A ct scan was performed the following day as part of pancreatic ca staging, and biliary leak was identified.The leak was pretty big and they performed an ir (interventional radiologist) guided percutaneous drain.There were no other relevant comorbidities were reported and no abnormal anatomy or scope tortuosity was present.The physician suspected that the leak was related to multiple attempts and since system was still pressurized without drainage of obstruction at the end of procedure.The rendezvous procedure was not completed.There was no fracture/detachment of the cannula during this case.There was no user harm.

• Brand Name: BEACON EUS ACCESS SYSTEM
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 10263884
• Report Number: 3004904811-2020-00021
• Device Sequence Number: 16881880
• Product Code: GAA
• UDI-Device Identifier: 10884521722583
• UDI-Public: 10884521722583
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DSA-090-01
• Device Catalogue Number: DSA-090-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR